FDA.reportPublic FDA data

ZITHROMAX

Product NDC
0069-3080
11-digit product format
000693080
Labeler code
0069
Product ID
0069-3080_209f8a1f-6366-4390-96d1-e35b231a0749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN DIHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050730
Marketing category
NDA
Marketing start
1996-06-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-3080-30EA - Each0069-30808fdefa4a-642f-478b-ab3c-a08ad7ba530d12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-3080ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]41Legacy NDC20250406_b749df83-49b0-433e-8a62-589a048dd716.zip